His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy (His-SYNC)
Congestive Heart Failure
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Wide QRS, Ventricular Dyssynchrony
Eligibility Criteria
Inclusion Criteria:
- Patients at least 18 years of age
- LV systolic dysfunction with LVEF ≤ 35%
- Evidence of intraventricular conduction delay with QRS duration > 120 msec
- NYHA Class II, III, and ambulatory Class IV heart failure with either ischemic or nonischemic cardiomyopathy and patients with NYHA Class I symptoms and ischemic cardiomyopathy
- Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm (SR), left bundle-branch block (LBBB) morphology, and QRS duration ≥ 150 msec, and NYHA Class II, III, or ambulatory Class IV patients on goal-directed medical therapy (GDMT) [Class I]
- LVEF ≤ 35%, SR with LBBB with QRS 120-149 msec on GDMT [Class IIa]
- LVEF ≤ 35%, SR with non-LBBB with QRS ≥ 150 msec on GDMT [Class IIa]
- LVEF ≤ 35%, in AF if medication or AV nodal ablation will allow near 100% pacing [Class IIa]
- LVEF ≤ 35% undergoing new or replacement device with anticipated >40% ventricular pacing on GDMT [Class IIa]
- LVEF ≤ 30%, ischemic etiology of HF, SR with LBBB ≥ 150 msec and NYHA Class I symptoms on GDMT [Class IIb]
- LVEF ≤ 35%, SR with non-LBBB with QRS 120-149 msec, NYHA Class III/ambulatory Class IV HF on GDMT [Class IIb] LVEF ≤ 35%, SR with non-LBBB with QRS ≥ 150 msec, NYHA Class II HF on GDMT [Class IIb]
Exclusion Criteria:
- Existing CRT device
- Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- Pregnancy
- Participation in other trials
- Difficulty with follow-up
Sites / Locations
- The University of California, Los Angeles
- Northwestern University
- Rush University Medical Center
- The University of Chicago
- Edward Hospital
- Indiana University
- Baptist Health Louisville
- Geisinger Wyoming Valley Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
His Bundle Pacing
Coronary Sinus Pacing
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.